Pfizer Excludes EU Biosimilar Experience From US Epoetin Application
Executive Summary
Even though US product has same cell line and drug product formulation as EU-approved Retacrit, Hospira subsidiary did not bridge to it in its US biosimilar application, meaning US FDA could not consider EU safety and efficacy experience.
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Pending Biosimilars
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.